17 results · 21ms · Sources: EU EUDAMED, US FDA

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TOUAREG CloseFit™ UNP 2.75mmD

FDA 510(k)
FDA Class 2 ·Dental

VT Sure

FDA UDI
PULMODYNE INC·00841470104962·

DISTRACTION SYSTEM

FDA UDI
BIOMET MICROFIXATION, INC·00841036071110·

FORZA SPACER SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

STA-CEPHASCREEN KIT

FDA 510(k)
FDA Class 2 ·Hematology

INTERSTIM II

FDA Adverse Event
Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·June 8, 2013

TIMESH OPTIMIZED SELF DRILLING SCREWS, 4.0 MM

FDA Adverse Event
Malfunction ·MEDTRONIC NEUROSURGERY·Product code HRS·June 17, 2011

PERCLOSE A-T SUTURE MEDIATED CLOSURE (SMC) SYSTEM

FDA Adverse Event
Injury ·ABBOTT VASCULAR-REDWOOD CITY·Product code MGB·September 8, 2008

EVERSENSE E3 SENSOR

FDA Adverse Event
Malfunction ·SENSEONICS INC.·Product code QHJ·November 20, 2025

MPACT FLAT PE HC LINER Ø32/E

FDA Adverse Event
Malfunction ·MEDACTA INTERNATIONAL SA·Product code LPH·February 19, 2016

ELEKTA LIMITED Elekta Synergy Platform, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

FDA Enforcement
Class II ·Ongoing·Elekta, Inc.·December 13, 2023

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 31, 2019

Artis zee biplane, Model Number 10094141

FDA Enforcement
Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. .

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 1, 2015

RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

FDA Enforcement
Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014

The Artis zee / zeego Angiography System is designed as a set of components that may be combined into different configurations to provide specialized angiography systems.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·December 10, 2014

Siemens Artis zee systems; dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

FDA Enforcement
Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 12, 2015